Capillary blood sampling device and method of using the same

Abstract

A body fluid sampling device ( 100 ) provides a user with the ability to sample and/or analyze a fluid in the body (body fluid) such as blood, puss or venom. The device ( 100 ) includes at least: a body fluid reservoir for containing the sampled body fluid and a fluid extraction mechanism including at least one conduit or needle connected to a conduit injection and retraction mechanism and a vacuum reservoir. After connecting the body fluid reservoir to the sampling device, a vacuum seal of the body fluid reservoir is adapted to be broken so as to cause the sucking of the body fluid into the body fluid reservoir. The sampling device ( 100 ) aids in executing a method ( 200 ) of the invention consisting of collecting body fluid such as capillary blood samples without the intervention of medically trained personnel. The sampling device ( 100 ) enables the user to: (a) sample a body fluid, optionally auto-sampling; (b) optionally, using one or more droplet(s) of the sampled body fluid, to immediately analyze the body fluid; and (c) provide a medical analysis tube ( 4000 ) meeting size and interface standards filled with the sampled body fluid for analysis in a point of care or medical lab. The sampling device includes a vacuum tube and an interface therefor. The vacuum tube provides the suction necessary to draw the body fluid from the user/patient and to fill the vacuum tube with the body fluid.

1 . A fluid sampling device including:
 (a) body fluid sampling means adapted for applying against the skin of a test subject, optionally the body fluid sampling means adapted for self-sampling, the body fluid sampling means comprising a cutting device for making a laceration for fluid sampling of the test subject;   (b) optionally, analysis means configured for using one or more droplet(s) of the sampled fluid to analyze the fluid; and   (c) a medical analysis vacuum tube adapted to be filled with a sample of fluid for analysis in a point of care or medical lab, and a needle for interfacing with the medical analysis vacuum tube meeting size and interface standards, the vacuum tube adapted to be filled with a sample of fluid for analysis at a point of care or medical lab and to provide suction necessary to fill the vacuum tube with the fluid.   
     
     
         2 . A method of fluid sampling using the device of  claim 1 , in a first step, a test subject is tested for a pathogen, and, if tested positive, in a second step, a treatment and/or quarantine protocol is initiated to ensure that a test subject having a positive test is handled in a manner which helps minimize the spread of the pathogen. 
     
     
         3 . A lancet adapted for making a laceration in the skin of a user/patient for a fluid sampling device of  claim 1  used for collecting a body fluid, wherein the cutting device is the lancet and the lancet is made in one piece of material and is disposed in a holder so as to enable its providing of the energy for movement and the guiding of its movement. 
     
     
         4 . The sampling device of  claim 1 , wherein a fluid extraction passage or conduit from the patient's wound to the vacuum tube is formed in a needle. 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . The fluid sampling device of  claim 1 , wherein the fluid is, at least in part, blood. 
     
     
         8 . The fluid sampling device of  claim 1 , wherein the fluid is, at least in part, puss. 
     
     
         9 . The fluid sampling device of  claim 1 , wherein the fluid is, at least in part, venom. 
     
     
         10 . The fluid sampling device of  claim 1 , wherein the device is adapted to use one or more droplet(s) of the sampled body fluid, to analyze the body fluid. 
     
     
         11 . (canceled) 
     
     
         12 . The fluid sampling device of  claim 1 , wherein the medical analysis tube is a standard medical analysis tube. 
     
     
         13 . A method of capillary blood sampling, wherein the method is adapted for self sampling, the method includes at least the steps of:
 a) placing an adhesive pad at the intended location for the capillary blood sampling, the adhesive pad including at least one mechanical localization feature and optionally visual indications;   b) lacerating the user/patient's skin with the cutting device of the sampling device of  claim 1 , thereby opening at least one wound in the user/patient's skin, the cutting device being positioned using the at least one mechanical localization feature of the adhesive pad;   c) collecting the patient's capillary blood with a fluid sampling device, the device being positioned on the at least one wound using the at least one mechanical localization feature of the adhesive pad and the device using vacuum to collect blood from the at least one wound and to fill a sample analysis tube; and   d) dressing the at least one wound using a foldable part of the adhesive pad.   
     
     
         14 . The fluid sampling device of  claim 1 , including an adhesive pad, the adhesive pad adapted for application at the intended location for the capillary blood sampling, the adhesive pad including at least one mechanical localization feature and optionally visual indications, the adhesive pad further containing at least one mechanical feature that allows for the precise placement of the cutting device and of the fluid sampling device and a foldable portion adapted for covering the at least one wound after the blood collection. 
     
     
         15 . The fluid sampling device of  claim 1 , or wherein the cutting device includes a lacerator including a lancet-adapted for making a one or more lacerations in the skin of a user/patient, wherein the lancet construction is made in one piece of material and provides the energy and the guiding for its movement. 
     
     
         16 . The device of  claim 1 , wherein the cutting device includes a lacerator including a lancet adapted for making a one or more lacerations in the skin of a user/patient, wherein the lacerator contains one blade for each of the one or more lacerations and makes the one or more lacerations simultaneously. 
     
     
         17 . The lacerator of  claim 14 , wherein when lacerating the patient's skin the trajectory of the at least one blades follows a trajectory that combines at least one rotary and at least one linear component of movement. 
     
     
         18 . (canceled) 
     
     
         19 . A lancet adapted for making a laceration in and under the surface of the skin of a user/patient for the sampling device of  claim 1  used for collecting a body fluid, wherein the cutting device follows a trajectory that creates a laceration under the surface of the user/patient's skin which is longer than the laceration it makes at the surface of the user/patient's skin, thereby favoring a quick healing of the wound after body fluid collection. 
     
     
         20 . The fluid sampling device of  claim 4 , wherein the medical analysis tube is a standard medical analysis tube. 
     
     
         21 . The fluid sampling device of  claim 5 , wherein the medical analysis tube is a standard medical analysis tube. 
     
     
         22 . The fluid sampling device of  claim 6 , wherein the medical analysis tube is a standard medical analysis tube. 
     
     
         23 . The fluid sampling device of  claim 7 , wherein the medical analysis tube is a standard medical analysis tube. 
     
     
         24 . The fluid sampling device of  claim 8 , wherein the medical analysis tube is a standard medical analysis tube.